1. Field of the Invention
The invention relates to a sterile and/or aseptic connection system and the use thereof in medical systems, especially in a set for cell separation for the sterile connection of further bags to an existing set. The invention relates in particular to two connecting elements which are connectable to each other in a sterile and/or aseptic manner, for transporting a fluid from one closed sterile bag into a second sterile bag.
2. Description of the Related Art
In prior art there are known numerous connectors which, in part, also enable a sterile connection. Said connection systems have become necessary in order to avoid any contaminations during the transfer of liquids which have to be kept sterile. This is for instance required for the transfer of infusion solutions, dialysis solutions or blood or blood components. In the field of infusion technology, several transfer systems are known which usually consist of a septum and the pertinent needle. When transferring liquids for the enteral feeding, spikes are used which have a larger flow volume.
While the sterility of the spikes and cannulas in the infusion, i.e. the direct use of the solutions. usually is sufficient, an increased sterility requirement has to be fulfilled regarding the sterility of blood or blood components to be stored or regarding the transfer a dialysis into the peritoneum in order to avoid a microbic contamination. Such solutions, on the one hand, provide an optimum culture medium for bacteria and a and, con the other hand, in most cases they also provide an optimum temperature environment. In case of a peritoneal solution, a germ could cause a peritonitis, i.e. an inflammation of the peritoneum, which can lead to irreparable damage. In the case of products to be stored, by ideal reproduction conditions the number of germs increases such that the immunological system is overstrained with a corresponding defense or resistance.
Therefore it is demanded and usual that for the transfer of blood from one closed system to a second system as well as for the transfer of solutions into the peritoneal cavity a sterile connection is used which provably cannot be contacted at its point of connection by the medical staff or by the patient himself or herself, not even inadvertently.
Therefore, in known sterile connectors the closing element itself, for instance the screw cap, is displaced inwardly and is protected against contact by a wrapping element drawn over the cap.
Contamination is also possible by air contact so that connection systems are also known which have an internal disinfecting means—for instance soaked little sponges—so that when the elements are assembled, a disinfectant like iodine PVP is set free and thereby a microbic contamination is prevented. But in such systems a part of the disinfectant passes into the tube connection. In view of this it has to be guaranteed that the disinfectant does not cause any damage or harm.
Furthermore it is known to establish the fluid connection only when the connection system has already been closed in a sterile manner. In WO 81/01105 there is shown a predetermined breaking point inside a tube which renders possible the flowing-through by breaking off the plastic pin. Said system, however, is produced with a fixed tube coupling and is sterilized thereafter, so that no connection is required.
In DE 29607437 U there is for instance described a medicotechnical connecting device with an internal threat th,e fluid connection of which is enabled by opening a break seal located in an inner cone axially spaced apart from the insertion end and therefore can only be penetrated by the outer cone of the counter connector.
A particularly quick and safe opening of the fluid path is realized by breaking off, as is for instance described in EP 0 555 927 A2. In said publication a connecting element is described which sealingly closes the end of a tube. A predetermined breaking line enables the breaking-off of the seal at the accurate position in order to open the outlet.
Also in WO 94/12224 there is shown a blood tube system which shows a clamp with a predetermined breaking point on a supply tube. By means of said clamp the tube can be alternatively only clamped off from the inlet section or it can be separated by breaking off at the predetermined breaking point,
It is already known from U.S. Pat. No 4,007,738 to provide an in-lying predetermined breaking point for a connecting element, with an end part of a connecting tube being broken off at a predetermined breaking point located within a small connecting tube This broken-off part can, however, result in an unwanted plugging of the line in the solution proposed there.
A connection system is known from U.S. Pat. No. 5,743,892 where a reservoir with disinfectant means is already provided which serves to disinfect the connection point when the female and male connecting elements are put together.
It is an object of the present invention to develop a connection system which satisfies high sterility requirements, but can nevertheless be produced in a simple and cost-saving manner. Said object is solved by the features mentioned in claim 1.